5th Sep 2006 07:02
Oxford Biomedica PLC05 September 2006 FOR IMMEDIATE RELEASE 5 SEPTEMBER 2006 OXFORD BIOMEDICA PLC INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2006 Oxford, UK: 5 September 2006 - Oxford BioMedica (LSE: OXB), a leading genetherapy company, announced today its interim financial results for the sixmonths ended 30 June 2006. Year to date highlights: Operational highlights: TroVax(R) (multiple cancers) • Encouraging results from five Phase II trials in colorectal and renal cancer presented at ASCO meeting • Phase II trial in prostate cancer fully recruited, and preliminary analysis shows high frequency of anti-tumour immune responses • US Southwest Oncology Group secures regulatory clearance for a Phase II trial in breast cancer • Special Protocol Assessment secured from the US FDA for Phase III TRIST study in renal cancer • QUASAR committed to conduct a Phase III trial in early-stage colorectal cancer • Licensing discussions at advanced stages of due diligence MetXia(R) (pancreatic cancer) • Two dose levels of cyclophosphamide successfully evaluated in second stage of the Phase II trial ProSavin(R) (Parkinson's disease) • Meeting request submitted to European agency as part of regulatory process to start clinical trials RetinoStat(R) (retinopathy) • Preclinical preparation underway to support submission to regulatory authorities to start clinical trials Technology licensing • Technology licence provided to VIRxSYS for AIDS/HIV product in Phase II trials • Strategic alliance partner, Sigma-Aldrich, launched second series of LentiVector(R)-RNAi reagents Financial highlights: • Revenue of £0.2 million (first half of 2005: £0.2 million) • Research and development costs of £9.5 million (first half of 2005: £4.8 million) • Loss after tax of £8.7 million (first half of 2005: £5.0 million) • Cash burn1 of £5.4 million (first half of 2005: £4.4 million) • Cash, cash equivalents and current financial assets at 30 June of £38.7 million (30 June 2005: £18.6 million) 1. Net cash used in operating activities plus purchase of non-current assets Commenting on the interim results, Oxford BioMedica's Chief Executive, ProfessorAlan Kingsman, said: "Our lead anti-cancer product, TroVax, continues togenerate promising clinical results in multiple cancer settings. Its progressioninto Phase III trials and a commercial collaboration should ensure that TroVaxis developed and commercialised to its full potential. Progress across thedevelopment pipeline could result in three further products entering clinicaldevelopment in 2006-07. With the Company in a strong financial position, we lookforward to pursuing our key development and commercial goals." Analyst meeting: An analyst briefing will be held at 10:00 am today at the offices of BuchananCommunications, 45 Moorfields, London EC2Y 9AE. Web cast: Simultaneously to the analyst briefing at 10.00 am, there will be a live audioweb cast of the results presentation. To connect to the web cast facility,please go to the Company's website: http://www.oxfordbiomedica.co.uk/approximately 10 minutes (09:50 am) before the start of the briefing. This willalso be available for replay shortly after the presentation. -Ends- For further information, please contact:Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000Buchanan CommunicationsScientific/Trade Press Enquiries: Katja Stout/ Susan Yu/ Gemma Bradley Tel: +44 (0)20 7886 8150 Northbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment of novel gene-based therapeutics with a focus on oncology andneurotherapy. The Company was established in 1995 as a spin out from OxfordUniversity, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-houseclinical, regulatory and manufacturing know-how. In oncology, the pipelineincludes two candidates in multiple Phase II trials, and a preclinical targetedantibody therapy in collaboration with Wyeth. A Phase III trial in renal cancerwith TroVax, the lead cancer immunotherapy candidate, is expected to start inthe second half of 2006. In neurotherapy, the Company's lead product is a genetherapy for Parkinson's disease, which is expected to enter clinical developmentin 2006, and four further preclinical candidates. The Company is underpinned byover 80 patent families, which represent one of the broadest patent estates inthe field. The Company has a staff of approximately 70 split between its main facilities inOxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.Oxford BioMedica has corporate collaborations with Wyeth, Intervet,Sigma-Aldrich, Viragen, MolMed, VIRxSYS and Kiadis; and has licensed technologyto a number of companies including Merck & Co, Biogen Idec and Pfizer. Further information is available at www.oxfordbiomedica.co.uk Chairman's and chief executive's report The first half of 2006 has seen the Company achieve several of its goals for theyear. Major events included the presentation of new Phase II data with TroVax inrenal and colorectal cancer; a Special Protocol Assessment agreement from the USFood and Drug Administration on the design and conduct of the Phase III trial ofTroVax in renal cancer; approval by the UK-based clinical trials network,QUASAR, of a proposed Phase III trial of TroVax in colorectal cancer; andregulatory progress towards the start of Phase I/II trials of ProSavin inParkinson's disease. Business development efforts have focused on thecommercialisation of TroVax, with several major pharmaceutical and biotechnologycompanies currently evaluating the programme. The leading prospective partnersare in advanced stages of due diligence and are assessing the commercialopportunity of TroVax in multiple cancer types. Discussions with these companieson development strategies and deal structures are ongoing. Oncology The Company and its partners have key expertise in tumour biology, immunologyand product development. Oxford BioMedica's oncology pipeline comprises threemajor product candidates as well as a product for treating cancer in companionanimals. These novel cancer therapies are designed to deliver a combination ofimproved efficacy and safety over existing treatments. The Company's in-house cancer pipeline is focussed on TroVax and MetXia.Clinical results from the Phase II programme with TroVax were reported at theAmerican Society of Clinical Oncology meeting in June 2006. The new dataincluded further indications of TroVax's efficacy in colorectal cancer and, forthe first time, preliminary indications of efficacy in renal cancer. During thefirst half of 2006, Oxford BioMedica expanded its clinical programme with newPhase II studies in renal cancer alongside standard therapies, and initiated atrial in prostate cancer. Preparations for the start of Phase III trials withTroVax progressed. In May 2006, the Company received a Special ProtocolAssessment agreement from the US Food and Drug Administration for the Phase IIITRIST (TroVax Renal Immunotherapy Survival Trial) study in renal cancer, and theclinical trials network, QUASAR, approved the design of a Phase III trial inearly-stage colorectal cancer. Patient recruitment continues in the second stage of the Phase II trial ofMetXia in pancreatic cancer. Data from this efficacy stage of the trial areexpected during the second half of 2006. The Company's partners, Wyeth andIntervet, are completing preparations for clinical/field trials with theirrespective cancer programmes and both product candidates continue to showexcellent results. TroVax(R) TroVax is Oxford BioMedica's lead cancer immunotherapy product candidate. It isdesigned to stimulate a specific anti-cancer immune response and has potentialapplication in many tumour types. The product induces an immune response againstthe tumour antigen 5T4, which is broadly distributed throughout a wide range ofsolid tumours. The product consists of a pox virus (MVA) gene-transfer system,which delivers the gene for 5T4. MVA is known to induce the breaking of immunetolerance to self antigens, such as 5T4, that are expressed from thisgene-delivery system. Once activated by TroVax, the components of the immunesystem, including antibodies and killer T-cells, migrate around the body seekingout and destroying cancer cells bearing 5T4. Approximately 150 patients have now been treated with TroVax in ten clinicaltrials in colorectal, renal and prostate cancer (collectively approximately 500doses). TroVax has attracted support from Cancer Research UK, the US NationalCancer Institute, and the clinical trials network, QUASAR. These organisationsare conducting or plan to conduct clinical trials with TroVax. The Annual Meeting of the American Society of Clinical Oncology in June 2006 wasan important forum for TroVax. Oxford BioMedica's scientists and externalclinical investigators from cancer centres in the USA and from Cancer ResearchUK presented data from five Phase II studies of TroVax. New data were presented from the Company's two completed Phase II trials in 36patients receiving TroVax as a first-line treatment for metastatic colorectalcancer alongside two standard-of-care chemotherapy regimens. An updated analysisof unaudited tumour response data showed that 95% of patients who received bothTroVax and at least six cycles of chemotherapy experienced disease control.Encouragingly, 60% showed complete or partial tumour responses (tumourshrinkage). In the analysis of patients that received at least two TroVaximmunisations and were therefore able to raise an anti-tumour immune response,TroVax extended median survival to 80 weeks from 72 weeks based on historicalcontrols for chemotherapy alone. Similarly, TroVax improved survival at twelvemonths from 70% to 90%. Importantly, as at 21 August 2006, nine patients (25%)remained alive with an average follow-up time of almost two and a half years.This level of survival is higher than expected and may indicate that TroVax isproviding a long-term therapeutic effect after treatment has halted. The Companyregards these data as encouraging and believes that, if these observations werereproduced in a large randomised study, they would be sufficient to supportproduct registration. As reported previously in 2005, the primary endpoints ofsafety and anti-tumour immunological responses were achieved in both trials andthe results confirmed the excellent safety profile of TroVax with no seriousadverse events being attributed to the product. Data from Cancer Research UK's Phase II trial of TroVax as an adjuvant therapyin colorectal cancer patients undergoing surgery for liver metastases showedthat 95% of patients produced an anti-tumour immune response. Hence, the primaryendpoint of immunological response was achieved. Again, TroVax was welltolerated in all patients with no serious adverse events associated with theproduct. Of the 20 patients recruited, 16 had successful surgical resection oftheir colorectal cancer liver metastases. All evaluable resected tumours werepositive for the 5T4 antigen, the target for TroVax, confirming previouslyreported data on the broad distribution of 5T4 on solid tumours. The first presentation of data from two studies of TroVax plus interleukin-2(IL-2) in renal cell carcinoma showed that two of the first six evaluablepatients (33%), who received at least three TroVax immunisations, had partialresponses based on industry-standard criteria known as Response EvaluationCriteria in Solid Tumours (RECIST). If reproduced in a larger study, thisresponse rate would compare favourably with the historic rate of 10% forpatients receiving IL-2 alone. To date, 34 of 50 patients have been recruitedinto the two trials, which are being conducted at two US clinical centres.TroVax treatment has been well tolerated, with no serious adverse eventsassociated with the product, which is consistent with its excellent safetyprofile in all trials. Across both Phase II trials of TroVax and IL-2 in renalcancer, 88% of evaluable patients have shown anti-tumour antibody responses to5T4. The antibody levels have been at the top end of the range previously seenin the Company's Phase II trials of TroVax in patients with colorectal cancerundergoing chemotherapy. These data endorse the Company's strategy to initiatethe Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) study in thiscancer setting. The Company announced in June 2006 that it was expanding its Phase II programmein renal cancer with three additional studies to assess TroVax in combinationwith other standard therapies: interferon-alpha (IFN - (a)) and sunitinib (Sutent(R)). These small open-label trials are designed to broaden clinical experiencewith TroVax and provide further support for the upcoming Phase III TRIST trial.Recruitment into the additional Phase II studies is ongoing in centres in the UKand the USA. To date, combining all five trials in renal cancer, 47 patientshave been enrolled. The Company's Phase III trial, TRIST, is on-track to commence recruitment in thesecond half of 2006. The manufacture of the trial material has been completedand both the drug and placebo materials are being prepared for shipment toclinical sites. Oxford BioMedica secured an agreement with the US Food and DrugAdministration (FDA) on a Special Protocol Assessment (SPA) in May 2006. Thewritten agreement from the FDA specifies the design, conduct, analysis andendpoints of the trial, which, if successful, will support an efficacy claim ina regulatory submission for product registration. The SPA was received at theend of the FDA's first review period following Oxford BioMedica's application inMarch 2006. In Europe, regulatory authorities in the countries chosen toparticipate in the study are reviewing the respective Clinical TrialApplications and the first approval has been obtained. The TRIST study will evaluate whether TroVax immunotherapy, in combination withfirst-line standard-of-care therapies, prolongs the survival of patients withlocally advanced or metastatic clear cell renal adenocarcinoma. Themulti-centre, randomised, double-blind, placebo-controlled trial will evaluateTroVax in combination with standard-of-care therapy, versus placebo withstandard of care. Standard-of-care therapies will be IL-2, IFN-(a) or Sutent(R).Study treatment will be stratified between the standard of care options toensure that the allocation of TroVax and placebo is rigorously balanced.Approximately 700 patients will be recruited at approximately 120 centres in theUSA, European Union, Eastern Europe and Israel. The primary endpoint isimprovement of survival and secondary endpoints include progression-freesurvival, tumour response rates and quality of life scores. The protocolincludes the appointment of an independent Safety and Efficacy Monitoring Board(SEMB) to assess the safety and potential efficacy of the drug combinations atvarious time points during the trial. Median survival for this patient group isapproximately 11 months. The duration of the trial will be determined by thenumber of survival events (deaths) in the study group. The trial is expected toreach a conclusion in 2008-09, which would support the Company's objective ofreaching product registration in 2009. The Company plans to seek 'orphan drug' designation for TroVax for treatment ofrenal cell carcinoma in both the USA and Europe. The granting of orphan drugstatus would provide Oxford BioMedica and its prospective commercial partnerwith various benefits in terms of regulatory exclusivity, assistance withclinical development and a waiver of filing fees. In the first half of 2006, Oxford BioMedica advanced its discussions with theQUASAR group, following their initial expression of interest in conducting aPhase III trial of TroVax in early-stage (Stage II/III) colorectal cancerpatients. QUASAR is a UK-based clinical trials network that is funded from avariety of sources including the UK Medical Research Council and the Departmentof Health. QUASAR completed its evaluation of TroVax and the proposed trial inMay 2006. QUASAR has confirmed its commitment to conduct the Phase III trial andis currently seeking funding through the appropriate agencies. The proposed QUASAR trial will be randomised and placebo-controlled and isexpected to enrol approximately 3,000 patients. TroVax or placebo will beadministered following surgery and adjuvant chemotherapy with the primaryendpoint of disease-free survival at three years. The study is expected to beconfigured to support product registration in Europe and the USA. The QUASARgroup has successfully conducted other large studies of adjuvant therapy incolorectal cancer, enrolling about 7,000 patients over the last seven years. Independently, the Company is planning a randomised trial in first-linetreatment of metastatic (Stage IV) colorectal cancer. The preliminary design ofthe trial is to evaluate TroVax alongside standard-of-care treatment, and thetrial could be configured as either a Phase IIb or a Phase III trial. The finaldesign of this trial will be dependent upon the outcome of licensing discussionswith prospective commercial partners. Oxford BioMedica started a Phase II trial of TroVax in patients with prostatecancer in May 2006 in the USA and completed its target enrolment of 24 patientsin July 2006. Enrolment criteria required patients to have hormone-refractoryprostate cancer with progressive disease, and to have previously receivedchemotherapy or to have refused chemotherapy. The open-label trial has two arms(12 patients each) to assess the efficacy of TroVax alone versus TroVax incombination with an approved treatment for prostate cancer, granulocytemacrophage-colony stimulating factor (GM-CSF). Initial safety data from theprostate cancer trial suggest that TroVax, alone or in combination with GM-CSF,is well tolerated in this patient group. To date, preliminary immunologicalanalysis has shown that 11 of 13 evaluable patients (85%), who have received atleast two TroVax immunisations, have mounted anti-tumour antibody responses and/or cellular responses to 5T4. Efficacy endpoints include objective responserate, progression-free survival, overall survival and changes inprostate-specific antigen (PSA) level, which is a recognised marker of diseasestatus. The Company will present further Phase II results from both the renal cancertrials and also the prostate cancer trial at the EORTC-NCI-AACR symposium inPrague, Czech Republic, in November 2006. Two abstracts have been accepted forpresentation at the meeting and the Company expects to report further data ontumour responses in renal cancer and preliminary efficacy data in prostatecancer. In addition to the trials described above, a US clinical trials co-operativegroup, Southwest Oncology Group (SWOG), has made progress towards the start of aPhase II trial with TroVax in breast cancer, which will be sponsored by the USNational Cancer Institute. In the first half of 2006, the proposed trial wassubmitted to the FDA and no issues were raised. In August 2006, the study wassubmitted to the US Recombinant DNA Advisory Committee and was similarlyaccepted, which means that the trial can now commence. The targeted population for this study will be late-stage breast cancer patientswho have received standard therapy and have either minimal residual disease orno evidence of disease. These patients are at high risk of relapse. The currentpublished literature indicates a median progression-free survival of 18 to 22months for this patient group. Approximately 120 patients will be enrolled inthis open-label trial. Key endpoints will include immunological response ratesand progression-free survival versus historical controls. SWOG, who isresponsible for all aspects of the trial, could commence patient enrolmentbefore the end of 2006 in centres in the USA. Should this trial provesuccessful, SWOG may conduct a Phase III trial in the same setting. The clinical data that have been generated to date place TroVax amongst theleading cancer immunotherapy candidates in development worldwide. The field ofcancer immunotherapy is growing, with several major pharmaceutical andbiotechnology companies committing significant research and developmentresources to this novel treatment approach. Oxford BioMedica is committed tosecuring suitable development and commercialisation partners for TroVax andseveral major pharmaceutical and biotechnology companies are evaluating theprogramme. The leading prospective partners are in advanced stages of duediligence and are assessing the commercial opportunity of TroVax in multiplecancer types. Discussions with these companies on development strategies anddeal structures are ongoing. MetXia(R) MetXia is Oxford BioMedica's gene-based cancer therapeutic candidate. Theproduct is based on a highly-engineered retrovirus gene delivery system, whichexpresses a specific human cytochrome P450 gene. Delivered in this way,cytochrome P450 activates the chemotherapeutic pro-drug cyclophosphamide at thetumour site, thereby increasing the effective concentration of the anti-tumour,cytotoxic derivative in the tumour mass. In principle, this localised activationshould enhance the efficacy of cyclophosphamide and reduce the need for systemicadministration. This in turn should reduce the dose-limiting toxicity of thedrug and expand the therapeutic window. MetXia is potentially useful in the treatment of a number of solid tumours andtheir metastases, particularly those where cyclophosphamide is currently used asa treatment. The Company is targeting its development efforts for MetXia on thetreatment of pancreatic cancer through direct administration of both MetXia andcyclophosphamide to the tumour. A two-stage Phase II trial is ongoing inpatients with non-resectable pancreatic tumours. The Company successfully completed the first stage of the trial in 2005. Patientrecruitment continues for the second stage of the trial using a fixed, optimaldose of MetXia and increasing doses of cyclophosphamide in up to 25 patients, attwo centres in the UK. The objective of the second stage is to determine theoptimal dose of cyclophosphamide and to evaluate clinical benefit in addition tosafety. Recruitment of patients into this part of the trial is purposefullystaged since each patient must be carefully reviewed for their response totherapy prior to treatment of subsequent patients. To date, two dose levels havebeen evaluated and six patients have received treatment. These patients are atan advanced stage of their disease, and most have previously failed to respondto other therapies. To date, there have been no serious adverse eventsassociated with MetXia, and further patients are being identified for treatmentat higher dose levels of cyclophosphamide. Oxford BioMedica expects to report further safety and preliminary outcome datafrom this trial in the second half of 2006. In addition, the Company intends toopen discussions with the regulatory authorities to determine the mostexpeditious route to obtain regulatory approval of MetXia for the treatment ofpancreatic cancer. 5T4 targeted antibody therapy (Wyeth) Wyeth licensed rights to Oxford BioMedica's proprietary antibody against the 5T4tumour antigen for the treatment of cancer in 2001. Wyeth is using the antibodyto develop an antibody-toxin conjugate based on its expertise with theanti-cancer agent calicheamicin. Like TroVax, the product could, in principle,be used to treat a range of cancers. The collaboration with Wyeth has thepotential to generate US$24 million in upfront and milestone payments, plusroyalties on product sales. In the first half of 2006, Wyeth continued its preparations for clinicaldevelopment of the targeted antibody therapy and is expected to submit anInvestigational New Drug (IND) application for the start of clinical trials. Thestart of clinical trials triggers a further milestone payment under the terms ofthe collaboration. TroVax-Vet(R) (Intervet) TroVax-Vet is Oxford BioMedica's veterinary 5T4 tumour antigen-targetedimmunotherapy programme for the treatment of cancer in companion animals,focusing on dogs and cats. The development and commercialisation collaborationwith Intervet, the animal health unit of Akzo Nobel, was signed in 2003.Intervet is one of the world's top veterinary pharmaceutical companies. Underthe terms of the collaboration, Intervet is responsible for the programme andOxford BioMedica receives development milestones and royalties on product sales. In the first half of 2006, Intervet completed its optimisation of the canineversion of TroVax-Vet and advanced to process development, which will define thecommercial manufacturing process. Intervet is planning clinical field trials ofcanine TroVax-Vet that would support regulatory approval in Europe through theveterinary unit of the European Agency for the Evaluation of Medicinal Products(EMEA). Neurotherapy Oxford BioMedica's neurotherapy pipeline addresses Parkinson's disease,vision-loss, nerve injury and acquired and inherited motor neuron disease. Thereare five therapeutic candidates based on the Company's proprietary LentiVector(R) technology. The neurotherapy programme continues to meet expectations inongoing preclinical development and advancement towards human trials. In the first half of 2006, the Company started the regulatory process for thestart of clinical trials with the most advanced product, ProSavin forParkinson's disease. In July 2006, the Company submitted a formal request for aregulatory meeting to discuss the ProSavin programme. The Company's vision-lossproduct, RetinoStat, and its motor neuron disease product, MoNuDin, haveprogressed into manufacturing development. In addition, the Company reported newpreclinical results with RetinoStat at an ophthalmology conference and presenteddata on three of its other neurotherapy product candidates at major gene therapymeetings. Given the commonality of the LentiVector system to all the programmes, theinvestment and infrastructure for ProSavin that relates to manufacturingscale-up and safety testing can be applied to the entire neurotherapy portfolio.Oxford BioMedica expects to initiate clinical trials with at least oneneurotherapy product per year, starting with ProSavin for Parkinson's disease. The neurotherapy portfolio continues to attract support from charitable andpatient organisations, primarily because the products could provide safe andeffective treatment options for diseases with unmet medical need. ProSavin(R) Oxford BioMedica's lead neurotherapy product candidate, ProSavin, is a novelapproach to the treatment of Parkinson's disease, which directly targets thecause of disease symptoms. ProSavin uses a LentiVector system to deliver thegenes for three enzymes that are required for the synthesis of dopamine. Theproduct is administered locally to the striatum, converting cells into areplacement dopamine factory within the brain. A confirmatory long-term preclinical efficacy study is ongoing in anindustry-standard model of Parkinson's disease. The study has previouslyconfirmed that a single treatment with ProSavin has a statistically significant(pRelated Shares:
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